MAUDE Adverse Event Report: ETHICON INC. TEMP PACING WIRE 24"(60CM) 2-0 BLU; ELECTRODE, PACEMAKER, TEMP

Catalog Number TPW30

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: additional information: - what do you mean by " was detected in 1 bx without insert of code tpw30 of lot mcq258 " ? please explain clearly? ans: was detected 1 bx with missing insert of code tpw30 lot mcq258.Was the product code tpw30 missing on the package label? ans: no.Was the lot mcq258 missing on the package label? ans: no.Was any component/package insert.Etc missing in the package? ans: missing insert in the package.It is stated "during the refurbishing of the product " what do you mean by that? was the package re-processed or re-sterilized? ans: the product was under a process of printed the legal information according to local regulation.Do you have any photos of the alleged issue? yes.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and a temporary pacing wire was used.During refurbishing of the temporary pacing wire, it was detected the box had no insert.There were no adverse patient consequences reported.Additional information had been requested.

Manufacturer Narrative

Product complaint #
=
> pc-000198808 date sent to the fda: 07/12/2018 the device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary - a photo was provided for analysis.Per photo analysis a box of tpw suture does not contain the applicable instructions for use of the device.The instructions for use are manually loaded during the packaging process.There are no additional layers of controls for this manual loading of the ifu.The assignable cause is human dependent controls.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.An empty opened folded box was returned for evaluation.During the visual inspection of the box, it was noted that the box was folded and empty; the box does not contain the insert.Due to condition of the sample the assignable cause of packaging labeling identification is a wrong, missing and/or mixed inserts.Unopened representative samples were returned for evaluation.The unopened samples were examined and not damaged on the packaging were noted; the samples were opened and no defects or damaged on the samples were found.Per condition of the unopened samples, no packaging labeling identification was found on the sample.

• Brand Name: TEMP PACING WIRE 24"(60CM) 2-0 BLU
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7614790
• MDR Text Key: 111717725
• Report Number: 2210968-2018-73559
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050884
• UDI-Public: 10705031050884
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: TPW30
• Device Lot Number: MCQ258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/13/2018; 07/12/2018
• Supplement Dates FDA Received: 07/12/2018; 08/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1